CK/LD ISOENZYME CONTROL PROD. #ACS CT101— 510(k) K800370
Substantially EquivalentAnalytical Control Systems, Inc.
FDA 510(k) clearance K800370 for CK/LD ISOENZYME CONTROL PROD. #ACS CT101, Substantially Equivalent on 1980-03-12. Applicant: Analytical Control Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Analytical Control Systems, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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